Dr. Reddy's Laboratories Hits 52-Week High After 'Clean Chit' from USFDA

20 Jul 2023 , 12:17 PM

Dr. Reddy’s Laboratories surges 2.6 %, reaching a fresh 52-week high at Rs 5,360 in intra-day deals on Thursday. The surge follows the company’s receipt of a ‘clean chit’ from the USFDA after a routine inspection at its Andhra Pradesh (AP) facility.

Since the end of May, the stock has rallied over 19 %, while the NSE Nifty 50 gained 7 % during the same period. The USFDA completed a Pre-Approval Inspection (PAI) and a routine GMP inspection at Dr. Reddy’s API manufacturing facility in Srikakulam, Andhra Pradesh, from July 10 to July 19.

The inspection concluded with zero observations and a classification of No Action Indicated (NAI), as stated in a release to the exchanges. Last week, the USFDA accepted the Biologics License Application (BLA) for Dr. Reddy’s proposed biosimilar rituximab candidate ‘DRL_RI’ for substantive review.

The rituximab biosimilar dossier was also accepted for review by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

Dr. Reddy’s had successfully completed clinical studies for the rituximab biosimilar candidate in January 2023, in preparation for filing in highly regulated markets.

Additionally, the company entered into an agreement with TEQ Green Power XI to access renewable power through solar and wind power plants via the Inter-State Transmission System (ISTS) under O2 Power SG captive structure.

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